Company:Carestream Health Inc.
Date of Enforcement Report: 9/2/2015
CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients. Recall Number Z-2449-2015
Carestream became aware of an issue with its DRX Evolution System v5.7 DIRECTVIEW Software v5.6 and v5.7. It has been determined that there is a software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph.
Carestream Health Inc, Rochester, NY on 8/7/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
Domestic: 76 units, Foreign: 160 units
Nationwide and Internationally